Abbott CELL-DYN 3000 Manuals

Manuals and User Guides for Abbott CELL-DYN 3000. We have 2 Abbott CELL-DYN 3000 manuals available for free PDF download: Operator's Manual, Troubleshooting Manual

Abbott CELL-DYN 3000 Operator's Manual

Abbott CELL-DYN 3000 Operator's Manual (542 pages)

Brand: Abbott | Category: Laboratory Equipment | Size: 5.45 MB

Table of Contents

Table of Contents
2
Introduction

22
- Foreword
  22
- Proprietary Information
  23
- Abbott Instrument Warranty
  24
- Text Conventions
  26
- Safety Icon Conventions
  27
- Revision Status
  28
- List No.
  28
- Manual Revision Log
  30
Chapter 1. System Description

32
- Introduction
  34
- Figure 1.2: CELL-DYN 3000CS
  35
- Intended Use
  36
- System Components
  38
  - Analyzer Components
    39
    
    Front Panel
    39
    
    Flow Panel
    41
    
    Figure 1.5: Analyzer Flow Panel Components
    43
    
    Left Side Panel
    45
    
    Figure 1.6: Analyzer Left Side Panel Components
    46
    
    Rear Panel
    48
  - Data Station
    50
    
    Overview
    50
  - Data Station Components
    50
    
    Front Panel
    51
    
    Right Side Panel
    52
    
    Figure 1.10: Data Station Rear Panel Components
    53
    
    Rear Panel
    53
  - Printer
    55
  - Sample Loader
    55
  - Reagent System
    55
    
    Introduction
    55
  - CELL-DYN Reagents
    56
Chapter 2. Installation

58
- Introduction
  60
- Initial Preparation
  61
  - Space Requirements
    61
  - Waste Requirements
    62
  - Power Requirements
    62
- Printer Installation
  62
  - Overview
    62
  - Graphics Printer
    63
  - Ticket Printer
    64
  - Figure 2.1: Data Station Rear Panel
    65
- Sample Loader
  67
  - Installation
    67
  - Mechanical and Electrical Setup
    67
  - Fluid Tubing Connection
    68
  - Figure 2.3: Sample Loader Tubing Connections
    68
  - Tube Racks Setup
    69
  - Power on
    70
Chapter 3. Principles of Operation

72
- Overview
  74
- Sample Aspiration
  75
- Sample Analysis Cycle Overview
  75
  - Sample Segments
    75
  - WBC Analysis
    75
  - RBC/PLT Analysis
    76
  - Hemoglobin Analysis
    76
  - Results Displayed
    76
  - Instrument Rinsed
    77
- WBC Measurement
  78
  - Overview
    78
  - Introduction to Flow Cytometry
    79
  - Figure 3.1: WBC Flow Cell
    80
  - Sheath Reagent
    81
  - Detection with the Optical Bench
    81
  - Figure 3.3: Optical Bench
    82
  - WBC Differential
    83
  - Figure 3.4: Mononuclear-Polymorphonuclear Scatter
    84
  - Figure 3.5: Neutrophil-Eosinophil Scatter
    85
  - Figure 3.6: Mononuclear Scatter
    86
  - Figure 3.7: WBC Histograms
    87
  - WBC Parameters
    88
  - WBC Flagging
    89
- RBC/PLT Measurement
  90
  - Overview
    90
  - Electrical Impedance Measurements
    90
  - Coincidence Passage Correction
    90
  - Rer
    91
  - Volumetric Metering
    91
  - RBC/PLT Measurement
    92
  - RBC Parameters
    93
  - Figure 3.10: RBC Data and Histogram
    93
- PLT Measurement
  95
  - Platelet Parameters
    95
  - Figure 3.11: PLT Data and Histogram
    96
  - Platelet Flagging
    97
- Hemoglobin Measurement
  98
  - Overview
    98
  - Hemoglobin Measurement Process
    98
  - HGB Parameter
    98
  - HGB Flagging
    98
- Operational Messages and Data Flagging
  99
  - Overview
    99
  - Instrument Fault and Status Conditions
    99
- Parameter Flagging Messages
  100
  - Dispersional Data Alerts
    101
  - Suspect Parameter Flags
    101
  - Suspect Population Flags
    104
  - Interpretive Messages
    106
  - Table 3.2: Interpretive Messages
    107
- References
  108
Chapter 4. System Specifications

110
- Physical Specifications - CELL-DYN 3000SL
  112
- Power Specifications - CELL-DYN 3000SL
  113
  - Consumption
    113
- Operational Specifications - CELL-DYN 3000SL
  114
  - Operating Environment
    114
  - Complete Cycle Times
    114
  - Approximate Aspiration Volumes (Whole Blood)
    114
  - Batch Size
    114
  - Throughput
    115
  - Collection Tube and Sample Volume
    115
- Bar Code Specifications - CELL-DYN 3000SL
  116
  - Bar Code Format
    116
  - Bar Code Label Specifications
    116
- Physical Specifications - CELL-DYN 3000CS
  117
- Power Specifications - CELL-DYN 3000CS
  118
  - Consumption
    118
- Operational Specifications - CELL-DYN 3000CS
  119
  - Operating Environment
    119
  - Complete Cycle Times
    119
  - Approximate Aspiration Volumes (Whole Blood)
    119
- Measurement Specifications
  120
  - Measurement Channels
    120
  - WBC and Differential
    120
  - Rbcs and Plts
    120
  - Hgb
    120
- Performance Specifications
  121
  - Background Counts
    121
  - Precision
    121
  - Hemogram Parameters
    121
  - WBC Differential Parameters
    122
  - Linearity
    122
  - Table 4.8: Precision of the WBC Differential Parameters
    122
  - Table 4.9: Linearity Specifications
    122
  - Accuracy
    123
  - Hemogram Parameters
    123
  - WBC Differential Parameters
    123
  - Carryover
    124
Chapter 5. Operating Instructions

126
- Introduction
  130
- Data Station Program Overview
  130
  - Main Menu Screen
    131
  - Conventions Used in this Manual
    132
- Setup Instructions
  134
  - Figure 5.3: Date/Time Setup Screen
    135
  - Procedure Date/Time
    136
  - Figure 5.4: Patient Limits Screen
    137
  - Procedure Patient Limit Sets
    138
  - Procedure Reagent Log Entry
    140
    
    Procedure Deleting Entries
    140
    
    Figure 5.6: QC Setup Menu Screen
    141
    
    Figure 5.7: X-B Setup Screen
    142
  - Procedure X-B Setup
    143
  - Range and Limit Entry and File Updating
    145
    
    QC Limits Entry
    145
    
    Figure 5.10: Replicate ID Entry Screen
    150
    
    Procedure QC File Setup
    151
    
    Procedure Customize QC Log Display
    154
    
    Showing Standard Groups
    155
    
    Procedure Customize QC Log Printout
    158
    
    Figure 5.15: Operation Setup Menu Screen
    159
    
    Procedure Bar Code Set up
    160
    
    Procedure Computer Setup
    163
    
    Figure 5.18: Units Selection Screen
    164
    
    Procedure Units Selection
    165
    
    Table 5.1: Report Units
    165
    
    Figure 5.19: Customize Displayed Report Screen
    166
    
    Procedure Customize Display
    167
    
    For the Graphics Printer
    170
    
    For Pre-Printed Tickets
    174
    
    For Blank Tickets
    176
- Routine Operation
  180
  - Introduction
    180
  - Data Station Run Menu
    181
    
    Data Station Run Screen
    182
    
    Status Box
    183
    
    Bulletin Line
    184
  - Flagging Diagnostics Screen
    185
  - Data Station Run Screen Soft Keys
    187
    
    Procedure Resistant RBC
    195
  - Sample Collection and Handling
    196
    
    Anticoagulant
    196
    
    Sample Stability
    196
    
    Interfering Substances
    197
    
    Sample Collection
    197
  - Sample Analysis
    198
    
    Introduction
    198
    
    Operator ID
    198
    
    Sample Identification
    198
    
    Alerts and Indicators
    199
    
    Instrument Start up
    201
  - Sample Analysis on the CELL-DYN 3000SL
    202
    
    Daily Quality Control Checks
    203
    
    Running Samples
    206
    
    Daily Shutdown
    208
  - Sample Analysis on the CELL-DYN 3000CS
    209
    
    Running Samples
    210
    
    Daily Shutdown
    212
  - Using the Work List
    213
    
    Work List Menu
    214
    
    Work List Soft Keys
    216
    
    Figure 5.35: Work List Setup Screen
    218
    
    Sample Analysis Using the Work List, Sample Loader Instruments
    220
    
    Sample Analysis with the Work List, Closed Sampler Instruments
    225
- Using the Data Log
  230
  - Introduction
    230
  - Data Log Menu
    230
  - Data Log Codes
    240
  - Data Log Set up Procedures
    241
    
    Customizing the Data Log Display
    241
    
    Procedure Customize Data Log Display
    242
    
    Standard Groups
    243
  - Data Review from the Data Log
    246
    
    Displaying a Record
    246
    
    Scrolling through the Data Log
    246
    
    Procedure Record Display
    247
    
    Editing a Record
    248
    
    Procedure Edit Specimen
    248
  - References
    250
Chapter 6. Calibration

252
- Introduction
  256
- Calibration Materials
  257
- General Information
  258
- Calibration Procedural Guidelines
  258
- Conventions Used in this Chapter
  259
- Calibration Procedural Summary
  260
- Whole Blood Calibration Guidelines
  261
- Calibration Overview
  266
  - Auto-Cal Overview
    266
    
    Auto-Cal Methodology
    266
    
    Auto-Cal Sample Capacity
    266
    
    Introduction
    266
    
    Calibration Requirements for Auto-Cal
    267
    
    Calibration Menu
    268
    
    Closed Mode Calibration Factors
    269
  - Manual Calibration Overview
    279
    
    Guidelines
    279
    
    Introduction
    279
  - Mode to Mode Calibration Overview
    280
    
    Auto-Cal Mode to Mode Calibration
    280
    
    Introduction
    280
    
    Manual Mode to Mode Calibration
    280
    
    Closed Mode Calibration Confirmation
    281
    
    Mode to Mode Calibration Preparation
    281
- Pre-Calibration Procedures
  282
  - Introduction
    282
  - Calibration Guidelines
    282
  - Instrument Logbook
    283
- Open Mode Procedures
  288
  - Auto-Cal Using the CELL-DYN Calibrator
    288
    
    Entering the Reference Values
    288
    
    Procedure
    288
    
    Starting Auto-Cal
    288
    
    Performing the Calibration
    289
    
    Calibration Factor Calculation
    291
    
    Determining Which Parameters Need Calibration
    292
    
    Calibration for All Parameters
    294
    
    Calibration for Individual Parameters
    295
    
    Completing Open Mode Calibration
    295
  - Auto-Cal Using Whole Blood Samples
    297
    
    Entering the Reference Values
    297
    
    Procedure
    297
    
    Starting Auto-Cal
    297
    
    Performing the Calibration
    298
    
    Calibration Factor Calculation
    300
    
    Determining Which Parameters Need Calibration
    301
    
    Table 6.4: Calibration Criteria Chart
    301
    
    Calibration for All Parameters
    303
    
    Calibration for Individual Parameters
    304
    
    Completing Whole Blood Open Mode Calibration
    304
  - Manual Calibration - Open Mode
    306
    
    Determining the Open Mode Mean
    306
    
    Preparing for Manual Calibration
    306
    
    Procedure
    306
    
    Calibration Factor Calculations
    307
    
    Determining Which Parameters Need Calibration
    308
    
    Calibrating the Open Mode
    310
    
    Completing Manual Calibration
    310
- Closed Mode Procedures
  314
  - Mode to Mode Auto-Cal, Sampler Loader Procedure
    314
    
    Determining Reference Values
    314
    
    Procedure
    314
    
    Starting Auto-Cal
    314
    
    Entering the Reference Values
    315
    
    Performing the Calibration
    316
    
    Calibration Factor Calculation
    318
    
    Determining Which Parameters Need Calibration
    319
    
    Table 6.6: Mode to Mode Calibration Criteria Chart
    319
    
    Calibration for All Parameters
    321
    
    Calibration for Individual Parameters
    322
    
    Completing Mode to Mode Calibration
    322
  - Mode to Mode Auto-Cal, Closed Sampler Procedure
    325
    
    Determining Reference Values
    325
    
    Procedure
    325
    
    Starting Auto-Cal
    325
    
    Entering the Reference Values
    326
    
    Performing the Calibration
    327
    
    Calibration Factor Calculation
    329
    
    Determining Which Parameters Need Calibration
    330
    
    Table 6.7: Mode to Mode Calibration Criteria Chart
    330
    
    Calibration for All Parameters
    332
    
    Calibration for Individual Parameters
    333
    
    Completing Mode to Mode Calibration
    333
  - Manual Mode to Mode Calibration
    336
    
    Determining the Open Mode Mean
    336
    
    Preparing for Manual Mode to Mode Calibration
    336
    
    Procedure
    336
    
    Determining the Closed Mode Mean
    337
    
    Difference Calculation
    337
    
    Determining Which Parameters Need Calibration
    338
    
    Calibrating the Closed Mode
    340
    
    Calibration Factor Calculation
    340
    
    Completing Mode to Mode Calibration
    341
- Post-Calibration Procedures
  344
  - Quality Control
    344
  - Calibration Back-Up
    344
  - References
    346
Chapter 7. Quality Control

348
- Introduction
  348
- Quality Control Menu
  352
- Figure 7.1: QC Menu Screen
  353
- Quality Control Guide
  362
  - General Information
    362
  - Running Controls
    362
    
    Control Material
    362
    
    Mixing and Handling
    362
    
    Assay Verification
    363
  - Westgard Rules
    364
    
    CELL-DYN 3000 Westgard Rules
    364
    
    Westgard Rule Violations
    365
  - X-B Analysis
    367
    
    Introduction
    367
    
    Lower/Upper Acceptance Limits
    367
    
    Action Limit
    368
    
    CELL-DYN Controls
    368
    
    Establishing the Target Value
    368
    
    Interpreting X-B Results
    368
    
    Target Value
    368
  - References
    370
Chapter 8. Precautions, Limitations and Hazards

372
- Limitations
  374
- Electrical Safety Precautions
  375
- Mechanical Safety Precautions
  376
- Chemical Safety Precautions
  376
- Decontamination Procedures
  377
  - Blood Samples
    377
- Reagent Storage and Handling
  378
- Printer Precautions
  378
- Sample Loader Precautions
  379
Chapter 9. Maintenance

380
- Introduction
  380
- Preventive Maintenance Schedule
  384
  - Daily
    384
  - Weekly
    384
  - Monthly
    384
  - As Required Maintenance
    384
  - Special Procedures
    385
- Analyzer Flow Panel Components Diagram
  385
- Special Protocols Menu
  388
- Figure 9.2: Special Protocols Screen
  389
- Daily
  394
  - Daily Maintenance Procedures
    394
    
    Auto-Clean
    394
    
    Sample Loader Aspiration Needle
    396
    
    Closed Sampler Aspiration Needle
    397
- Weekly
  398
  - Weekly Maintenance Procedures
    398
    
    Shear Valve
    398
    
    Figure 9.6: Shear Valve Assembly
    399
    
    Aspiration Peristaltic Pump Tubing
    401
    
    Figure 9.7: Aspiration Peristaltic Pump
    402
    
    Sample Loader Tray, Racks and Safety Cover
    403
- Monthly
  406
  - Monthly Maintenance Procedures
    406
    
    Reagent Syringes
    406
    
    WBC Transfer Peristaltic Pump Tubing
    409
    
    Air Filters
    411
    
    Figure 9.10: Analyzer Left Side Panel
    411
    
    Figure 9.11: Data Station Rear Panel
    412
    
    Extended Auto-Clean
    413
    
    Figure 9.12: Special Protocols: Extended Auto-Clean Screen
    414
- As Required
  416
  - As Required Maintenance
    416
    
    RBC/PLT Aperture Plate
    416
    
    Procedure
    417
    
    Figure 9.14: Transducer Assembly and Aperture Plate
    418
    
    Vacuum Accumulator Cleaning Procedure
    422
- Special Procedures
  424
Chapter 10. Troubleshooting

428
- Introduction
  428
- Introduction
  430
- Diagnostics Menu
  432
- Troubleshooting Guide
  454
  - Introduction to Troubleshooting
    454
  - Obtaining Technical Assistance
    455
  - Troubleshooting Procedures
    456
    
    Power on Procedure
    456
    
    Initializing the System
    457
    
    Power off Procedure
    457
    
    Unclogging the Open Sample Aspiration Probe
    459
    
    Figure 10.21: Open Sample Aspiration Probe
    460
  - Operator-Replaceable Components
    461
    
    Checking or Changing the Analyzer Fuse
    461
    
    Operator-Replaceable Fuse
    461
    
    Sample Loader Aspiration Needle or Vent Needle
    462
    
    Needle Assembly
    463
    
    Aperture
    465
    
    Syringes
    466
- Troubleshooting Tips and Techniques
  467
- Messages and Fault Conditions
  472
  - Overview
    472
  - Summary of Table
    474
    
    Table 10.1: Instrument Status Conditions
    475
    
    Instrument Status Conditions
    476
    
    Table 10.2: General Fault Conditions
    483
    
    General Fault Conditions
    491
    
    Sample-Related Fault Conditions
    497
    
    Table 10.3: Sample-Related Fault Conditions
    498
    
    Table 10.4: Non-Functional Fault Conditions
    503
    
    Non-Functional Fault Conditions
    505
- Introduction
  512
- Printing Graphics Reports
  512
- Printing Tickets
  512
  - Loading Individual Tickets
    513
- Maintenance
  516
- Troubleshooting
  517
Chapter 11 . Printer

520
Chapter 12. Sample Loader

520
- Overview
  520
- Labels
  521
  - CELL-DYN Bar Code Labels
    521
  - CELL-DYN Q Labels
    521
  - Bar Code Label Placement
    522
- Sample Loader Components
  523
- Sample Loader Operation Keyboard Keys
  524
- Operating Principles
  526
  - Functional Description
    526
    
    Figure 12.6: Tower Stations
    527
    
    Figure 12.7: Tube Racks
    529
  - Function Sequence
    531
- Routine Operating Procedures
  534
- Maintenance
  534
- Installation
  534
- Troubleshooting
  534
Appendix A. Bar Codes

536
- Introduction to Bar Codes
  536
  - Bar Coding Function
    536
  - Understanding the Label "Code
    537
  - Bar Code Types and Characteristics
    537
- CELL-DYN 3000 Bar Code Specifications
  538
  - Bar Code Label Specifications
    538
  - CELL-DYN Bar Code Labels
    539
  - CELL-DYN Q Labels
    539
  - Figure A.1: Bar Code Label Specifications
    539
  - Bar Code Label Placement
    540
  - Figure A.2: Tube Labeling Requirements
    540
- Acknowledgment
  541

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